MAUDE Adverse Event Report: BIO-DETEK INCORPORATED CPR STAT PADZ HVP MULTI-FUNCTION CPR ELECTRODES -

Model Number	8900-0402
Medical Device Problem Codes	Arcing of Electrodes (2289); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	02/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Event or Problem Description
Complainant alleged that while attempting to defibrillate a patient (age & gender unknown), an arc occurred at the electrode pads.After removing the electrode pads, burns were found on the patient's skin.Complainant indicated that the clinician obtained another set of electrode pads to continue treating the patient and after the sixth defibrillation, the doctor stopped the resuscitation.Complainant indicate that the patient sustained burns, the degree of patient burns and any adverse effect was not available.
Additional Manufacturer Narrative
This report was inadvertently submitted as a duplicate.The reported event was originally reported under medwatch 1220908-2020-00029.This claim is being closed as a duplicate.Evaluation results: the device was not returned, instead the suspect electrode pads were received for evaluation.The electrodes were adhered together with the cpr puck in between the pads.The pads were seperated and visually inspected.There was evidence of arcing on the outer edge of the sternum pad.The energy concentration observed on the pads showed that the energy took the path of least resistance.Which indicates that there was poor coupling of the electrode pads to the patient's skin (air).This report has been closed as poor coupling (continuity).

• Brand Name: CPR STAT PADZ HVP MULTI-FUNCTION CPR ELECTRODES -
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BIO-DETEK INCORPORATED; 525 narragansett park drive; pawtucket RI 02861
• MDR Report Key: 10018617
• Report Number: 1218058-2020-00042
• Device Sequence Number: 3159350
• Product Code: MKJ
• UDI-Device Identifier: 00847946016319
• UDI-Public: 00847946016319
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: 8900-0402
• Device Catalogue Number: 8900-0402
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 05/01/2020
• Supplement Report FDA Received Date: 05/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other